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news.SciClone Pharmaceuticals has released results from the company's Phase 2 proof of concept study of SCV-07 for the prevention of severe oral mucositis (OM; WHO grades 3-4) in patients with advanced head and neck cancer.
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The results showed that the incidence of severe OM after 5 weeks of chemoradiation was 30% lower in the patients in the high dose treatment arm (0.1mg/kg; 17 patients) compared to the 20 patients who received placebo (29% vs. 42%). A post hoc data analysis of ulcerative mucositis (WHO grades 2-4) was also conducted. The high dose of SCV-07 prevented the onset of any ulcerative mucositis in 24% of patients at doses of radiation up to 50Gy (after approximately 5 weeks of treatment) while 100% of patients in the placebo group suffered from ulcerative mucositis at 35Gy (after approximately 3.5 weeks of treatment).
Additionally, the high dose SCV-07 group also showed improvement over placebo for exploratory endpoints, including the use of gastric tube feedings, unplanned office or emergency room visits, and breaks in planned course of radiation therapy of one week or longer.
Reportedly, the incidence of severe OM after 5 weeks of chemoradiation was 50% higher in the patients in the low-dose treatment arm (0.02mg/kg; 20 patients) compared to the 20 patients who received placebo (63% vs. 42%). However, the post hoc data analysis of ulcerative mucositis showed that the low dose of SCV-07 prevented the onset of any ulcerative mucositis in 5% of patients at doses of radiation up to 50Gy compared to 100% of patients in the placebo group who suffered from ulcerative mucositis at 35Gy.
SciClone Pharmaceuticals said that in case of exploratory endpoints, the low dose group showed similar results to the placebo group. These results suggest that SCV-07 may be acting on different biological pathways at different doses.
SciClone stated that it has formed a scientific advisory board (SAB) to provide guidance and oversight for the company’s ongoing clinical development of SCV-07 for this indication. The newly established SAB, which includes medical and radiation oncology thought leaders, is working with SciClone to design the clinical development strategy for the OM program based on findings from this study.
Stephen Sonis, chief of the division of oral medicine at the Dana-Farber Cancer Institute, senior surgeon at Brigham and Women’s Hospital, clinical professor of oral medicine at Harvard, said: “SAB members were encouraged by the findings from SciClone’s Phase 2 proof of concept study which suggested a consistent trend favoring patients in the trial’s high dose group. Furthermore, the data from the study offered insight into study design for the next Phase 2 trial.”
Friedhelm Blobel, president and CEO of SciClone, said: “Through this newly formed SAB, we believe that we have assembled a team of opinion leaders in the area of oral mucositis. We are grateful that these experts have agreed to provide their guidance to this program.
“We appreciate the efforts already put forth by this Board in assisting the ongoing clinical development of SCV-07 for OM and look forward to the contributions that they will make as we continue to advance the program.”